Get Involved Early

May 1, 2003
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Dear Editor,

I was impressed with two pieces of writing-"The Big Picture" (Quality, Oct. 2002, p. 6) and Scott Dalgleish's ISO 9000 'Hindrance' article (Oct. 2002, p. 64).

I would like to share a quality story with the readers. We are a contract manufacturing company in the medical device arena. A customer provides a design; we follow it through its design transfer phase and recommend revisions along the way to production. Experience has taught us to pay attention to the design details as early as we can. Many times the designer has not the quality background to foresee production issues with their designed device. We stress immediate attention to detail when we meet a potential (customer) designer.

A device intended for use by a physician on a patient requires the utmost quality. A label on the package is typically the first impression the doctor, or nurse, has of your company and the device inside the package. When we received a 'blueprint' of the label text we found a spelling error. How would a doctor perceive this in an operating room environment? While we may belittle spell-check, or perhaps do not employ a proof reader, if the designer had quality in their minds at the outset of the design, the spelling error would not have made its way through onto a finished device (it didn't by the way). I say we push the designers to the ISO/QA school of thought in the sense that they should employ quality based processes when designing a product or service. Improve the process and we'll all be on our way!

Keep up the good work; Quality magazine is very informative.

Henry Couture
QA Manager
Sequel Special Products
Waterbury, CT

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